Course Description

Course title:

Medical Device Pre-Market Approval Process in Korea

Course ID: N155

Course Description:

This course provides a comprehensive review of the Korean medical device pre-market approval process requirements released in April 2012. It examines current regulatory documents, including different market access programs, classification systems, device categories, and manufacturing practices specific to Korea.

As part of this course, learners will be walked through the decision-making process of choosing which market access programs correlate to which medical devices (including exceptions to the rule). The course also includes a review of Korea FDA (KFDA) inspection policies.

Watch the Course Trailer:

Learning Objectives:

Upon successfully completing this course, learners will be able to:

Apply the different requirements of Korean regulations for medical devices during your market access process

Understand the mechanism of categories and classifications of medical devices in Korea

Plan a Korean medical device listing or notification process for a device

In addition a detailed understanding of Quality systems requirements (ISO 13485), and Risk management (ISO 14971) are required to successfully achieve the above stated objectives. You can learn about these topics in the following WMDO courses:

About WMDO

WMDO provides you with the extensive knowledge and unrivaled experience of the medical device industry's leading experts and authorities to deliver the latest and most effective online medical device training available in the world.